Biotech Values

[jq1234]

Difficult to say without following the company. I don't think PDUFA V has guidance on this, but the company could have had some interaction with FDA since PDUFA V, they got some guidance - not necessarily due to PDUFA V - that blinded safety data are preferred over mixed blinded/unblinded safety data - some data would have been collected blinded while some would have been collected unblinded, making it more difficult to interpret if there is any issue. Or there could be some safety imbalance from interim or DMC that the company felt it would be better to have all safety data collected under blinded condition.